Label: BUSCAPINA- acetaminophen, caffeine, pyrilamine maleate tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 5, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

    Buscapina

  • Active Ingredients (in each caplet)

    Acetaminophen 500mg, Caffeine 60mg, and Pyrilamine maleate 15mg 

  • Purpose

    Pain Reliever, Diuretic, Antihistamine, Multi-Symptom Relief

  • Uses

    • For the temporary relief of these symptoms associated with menstrual periods
    • Cramps
    • Bloating
    • Water- weight gain
    • Headache
    • Backache
    • Muscle aches
    • Fatigue
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 6 tablets in 24 hours, which is the maximum daily amount for this product
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product.

    Allergy warning: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • hives
    • facial swelling
    • asthma (wheezing)
    • shock

    If a skin or general allergic reaction occurs, stop use and seek medical help right away.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you have ever had an allergic reaction to this product or any of its ingredients
  • Ask a doctor before use if you have

    • Liver disease
    • Glaucoma
    • difficulty in urination due to enlargement of the prostate gland
    • a breathing problem such as emphysema or chronic bronchitis
  • Ask a doctor or pharmacist before use if you are

    • Taking the blood thinning drug warfarin
    • Taking sedatives or tranquilizers
  • When using this product

    • you may get drowsy
    • avoid alcoholic drinks
    • excitability may occur, especially in children
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • limit the use of caffeine-containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains aboout as much caffeine as a cup of coffee.
  • Stop use and ask a doctor if

    • new symptoms appear
    • redness or swelling is present
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
  • If pregnant or breast-feeding

    Ask a health professional before use.

  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • Do not exceed recommended dosage.
    • Adults and children 12 years and over: Take 2 tablets with water. Repeat every 6 hours, as needed. Do not exceed 6 tablets per day
    • Children under 12 years: Consult a doctor
  • Other Information

    • Store at room temperature
    • TAMPER EVIDENT; DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
  • Inactive ingredients

    • Colloidal silicon dioxide
    • Hypromellose
    • Magnesium stearate
    • Microcrystalline cellulose
    • Polyethylene glycol
    • Polyvinyl pyrrolidone
    • Pregelatinized starch
    • Titanium dioxide
    • Talc
  • Questions or comments?

    Call toll free 1-844-832-1138 Monday through Friday 9AM - 5PM or www.healthlifeofusa.com

  • BuscapinaAcetaminophen 500mgCaffeine 60mgPyrilamine maleate 15mg24 CapletsDistributed By:OPMXSan Diego, CA, 92154

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  • INGREDIENTS AND APPEARANCE
    BUSCAPINA 
    acetaminophen, caffeine, pyrilamine maleate tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-130
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE60 mg
    PYRILAMINE MALEATE (UNII: R35D29L3ZA) (PYRILAMINE - UNII:HPE317O9TL) PYRILAMINE MALEATE15 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize17mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-130-2424 in 1 BOTTLE; Type 0: Not a Combination Product01/05/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34301/05/2018
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elysium Pharmaceuticals Limited915664486manufacture(69729-130)